What is Chronic Local Toxicity Study?

Chronic local toxicity studies are a type of preclinical toxicity assessment in animals designed to assess the potential adverse effects of a substance or drug on a specific target organ or system. This research involves repeated administration of a test substance to animals over an extended period of time, from a few weeks to several months or longer. The purpose of chronic local toxicity studies of ophthalmic products is to determine the local effects of the substance on the target organ or system, such as the eyes. The study assessed various parameters such as changes in organ weights, histopathological examination of tissues, and functional or behavioral observations to identify any signs of toxicity or adverse effects. The results of chronic local toxicity studies provide valuable information for assessing potential compounds' safety and determining appropriate doses or exposure levels for human use or further clinical development.

Service Overview

As a preclinical ophthalmology research CRO, Ace Therapeutics conducts safety and efficacy assessments across all ocular indications. These ocular toxicology studies can be performed under GLP or non-GLP conditions. We are pleased to offer unrivaled chronic local toxicity studies for your ophthalmic products, which can also be used for early-stage studies.

At Ace Therapeutics, our talented scientists understand that chronic local toxicity studies provide conclusions about the long-term effects of test substances in models (rats, rabbits, or guinea pigs) and humans. Our goal is to always provide the most comprehensive and regulatory-compliant chronic local toxicity study reports to better support the clinical trials of your ophthalmic products.

Access Ace Therapeutics' Chronic Local Toxicity Study of Ophthalmic Compounds

Ace Therapeutics quantifies acute local toxicity using the following protocol:

• Experiment Procedure

• Eye examination of the test animals (albino rabbits): Before the test, the animals should adapt to the animal laboratory environment for at least 3 days. 24 hours before the trial, both eyes of the experimental animals should be thoroughly examined. Animals with corneal defects or conjunctival lesions with eye irritation symptoms should not be used.
• Groups: 30 albino rabbits were divided into three groups, including the test product group, the vehicle (when applicable) group, and the control substance group, with at least 5 males and 5 females per group.
• Administration: Test substances (eye drops, gels, inserts, implants, patches, ointments, creams, etc.) were applied to the eye by the optimal route of administration, such as topical ocular application, retrobulbar, intravitreal injection (IVT), subconjunctival injection, subtenon injection (SBT), periocular injection, intrastromal injection, intracameral injection, subretinal, transscleral, iontophoresis, etc., according to product characteristics. Multiple doses per day for 28 days or more.
• Evaluation:
  Daily measurement of body weight and food consumption.
  Weekly measurements of body weight and food consumption.
  Hematology, clinical biochemistry, and urinalysis.
  Gross pathology (major organ weights and ocular histology).
• Guidelines: OECD guideline for the testing of chemicals -Test No. 410: Repeated Dose Dermal Toxicity.

Note*: Ace Therapeutics' chronic local toxicity studies can be adjusted to meet specific requirements according to the characteristics of your product, such as structural characteristics, physicochemical properties, indication characteristics, and test purposes. Importantly, our talented scientists will also conduct a comprehensive evaluation of the test results in combination with other pharmacological and toxicological information to help you reduce asset risks before entering IND-supported studies.

With strong professional knowledge and an advanced technology platform, Ace Therapeutics provides comprehensive ocular toxicity study services. Our professional ocular toxicology research team will evaluate your ophthalmic products by designing the most suitable chronic local toxicity procool. If you are interested in our services or need more detailed information, please feel free to contact us. Our experienced scientists are ready to help you!

• Acute Local Toxicity Testing of Ophthalmic Drugs
• Maximum Tolerated Dose (MTD) Testing of Ophthalmic Drugs
• Lacrimation Testing of Ophthalmic Drugs
• Corneal Anesthesia Testing of Ophthalmic Drugs
• Pupil Diameter Testing of Ophthalmic Drugs

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